PHENOXYBENZAMINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC C04AX02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBurel Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC04AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3557347302
100 CAPSULE in 1 BOTTLE (35573-473-02)

Annotations

UNII (FDA Substance ID)

X1IEG24OHL

PHENOXYBENZAMINE HYDROCHLORIDE

RxCUI 71512

Orange Book

A215600

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Phenoxybenzamine Hydrochloride Capsule

Raw payload (JSON)

{
  "unii": {
    "unii": "X1IEG24OHL",
    "rxcui": "71512",
    "inchikey": "VBCPVIWPDJVHAN-UHFFFAOYSA-N",
    "display_name": "PHENOXYBENZAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "29f6dae9-44ef-404d-afa9-65979a4064c2": {
      "match": "brand_token",
      "title": "PHENOXYBENZAMINE HCL POWDER [AX PHARMACEUTICAL CORP.]",
      "spl_version": "1",
      "published_date": "2025-02-14"
    }
  },
  "productid": "35573-473_609aa41e-4cb5-4cdf-9137-f429c21b4fab",
  "productndc": "35573-473",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215600",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 8, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENOXYBENZAMINE HYDROCHLORIDE",
  "shortage_reason": "Phenoxybenzamine Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "PHENOXYBENZAMINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215600",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PHENOXYBENZAMINE HYDROCHLORIDE",
  "start_marketing_date": "20230508",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C04AX02.

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